Associate Consultant-Case Management

Indianapolis, Indiana
August 25 2019
Life Sciences
Position Type
Full Time
Organization Type
Job Type
The responsibilities of the Global Patient Safety (GPS) Regional Center (RC) Associate/Senior Associate/Associate Consultant (known as Associate) is for the management and oversight of adverse events. This includes the management of adverse events within the GPS Systems, required follow up activities, and ensuring timely expedited reporting. The role requires process and quality oversight and procedural and regulatory expertise. The RC Associate is expected to effectively represent Global Patient Safety through collaboration with internal and external GPS colleagues and business partners and be constantly striving for efficiencies while maintaining compliance. An associate's responsibilities can vary depending on the needs and focus of a particular team or the associate's primary role (e.g., Global Lead Associate, Literature Associate).

Key Responsibilities

Objective: Management of Adverse Events

Apply clinical judgement, critical thinking, regulatory knowledge and a quality mindset to the management of adverse event data within our GPS Systems to ensure compliance, efficiency and data integrity.

AE Data Management
  • Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities. These activities may include but are not limited to:
    • Management of adverse events arising from various sources including but not limited to literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous, pregnancy, devices, Lilly Market Research (LMR), etc.
    • Ensure the following: appropriate serious outcome criteria for adverse events is selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review.
    • Complete or verify MedDRA coding
    • Identify concomitant medication and relevant medical history
  • Prepare serious adverse event forms for clinical trials and provide testing assistance for Inform studies.
  • Collaboratively work with teams regarding any electronic database collection and determine how to ensure integrity of the SAE data during the course of the clinical trial.
  • Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel.
  • Provide device expertise including: support device-related and CATool case management activities, resolve issues related to CATool use to ensure appropriate linking of adverse event/product complaint information, complete follow-up/PC actions items to ensure relevant product information is updated in a timely fashion.
Expedited Reporting
  • Review and analyze individual adverse event reports to establish need to report to local regulatory authorities, and submit as necessary, in accordance to local regulation and internal procedures.
  • Responsible for the completeness and accuracy of submitted reports.
  • Comply with internal and external timelines for managing adverse event data entry, and expedited reporting processes as appropriate.

Objective: Global GPS Oversight and Support

Utilize clinical case management expertise to provide oversight to ensure that adverse event data is managed appropriately to internal standards and external regulations by Lilly, partners and vendors.

Case Quality and Data Oversight; Vendor Oversight
  • Apply GPS quality practices to the adverse events managed with GPS systems.
  • Participate in local, regional and global audits and inspections.
  • Provide study oversight, which may include the following: maintenance of EPM and late phase clinical trials information, perform end of study related activities, and maintenance of RSI IB collaboration site.
Procedural and Regulatory Expertise
  • Develop detailed knowledge of GPS standards regarding management of adverse event reports.
  • Keep current on global PV regulations, changes and practices related to GPS.
  • Act as subject matter expert for the creation, revision, and maintenance of GPS standard operating procedures and training. Provide training as required.
  • Develop an understanding/expertise of pharmacovigilance regulations
  • Understand the roles of the EU qualified person (QP) and ensure support is provided to fulfill the QP legal responsibilities
  • Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues.
  • Prioritize work to ensure internal and regulatory timelines are met.
  • Ensure schedule management and workflow oversight is provided to all CCM associated vendors.
  • Understand and apply GPS business practices.
Objective: Collaboration with Internal Partners and External Customers

Provide expertise in PV knowledge of individual case processes and requirements to other functions within GPS and Lilly to ensure efficiency in execution of responsibilities.

Global Support to PV Personnel/Business Units and Interacting Functions
  • Provide PV expertise to support Affiliates, and Business Units, Medical, and Call Centers in GPS related activities as necessary
  • Partner to provide CCM expertise and communicate with colleagues including but not limited to Surveillance, Medical, Pharmacoepidemiology, Data Management, Business Alliance, Corporate, Quality and Legal.
  • Be a pro-active and consistent member of medical team meetings (PFT, DSST/SST, Inv. Training). Provide individual case knowledge to facilitate reconciliation and trial data completion.
  • Provide expertise and authoring of ERB line listings or Investigator line listings with input from medical, toxicology, surveillance, and GPS medical
  • Provide expertise for the process flow for receiving serious adverse event data and changes or discoveries during studies
  • Liaison with Business Alliance for business partner, issues, review of safety agreements, process changes required to ensure business continuity
  • Be a pro-active member representing CCM providing expertise on local or global projects to ensure CCM are consistently delivering innovation and improvements

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.


Basic Qualifications

  • Bachelor of Science degree in a Clinical related field preferred in the area of pharmaceutical/biological science
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Information

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Additional Skills/Preferences

  • Critical thinking to solve problems, and make decisions autonomously, and as part of a team
  • Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems.
  • Effective communication skills, both oral and written
  • Proficient high-level end-user computer skills (i.e. word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines)
  • Ability to learn quickly and adapt to a changing environment
  • Demonstrated interpersonal skills; ability to work as part of a team both in person and virtually
  • Ability to focus on the big picture; use of logic to solve problems
  • Ability to manage multiple concurrent tasks; good organizational skills
  • Attention to detail; ability to focus for long periods of time on detailed information
  • English language skills - fluent written and verbal communications
  • Ability to work effectively in a global team and apply understanding of diversity and inclusion.
Preferred Skills:
  • Demonstrated PV experience
  • Knowledge of global regulations with respect to adverse event reporting for both drugs and devices
  • Knowledge of GPS safety database
  • Knowledge of CPQA product complaint database
  • Project Management skills